Mutual Recognition Procedure Research Articles

Overview of Drug Approval Process and Post Approval Changes in Europe

The European Medicines Agency (EMA) is facilitate development and access to medicine, evaluating applications for marketing authorization, monitoring the safety of medicines across their lifecycle and providing information to healthcare professionals and patients.
 In order to obtain a marketing authorization in Europe, a medicine must meet a number of criteria before it can be filed with the European Medicines Agency (EMA). This article is looks at the EMA’s Drug approval process and post approval changes. The decentralized regulatory body, or EMA, is in charge of overseeing the safety of food and drug (pharmaceutical products) in Europe. The applications are examined, and member state looks over the safety and effectiveness data before approving the drug. EU establishes 4 different drug approval processes:
 1) National Procedure
 2) Decentralized Procedure
 3) Centralized Procedure
 4) Mutual Recognition Procedure
 The goal of the current study is to clarify the function of post-approval change management in preventing non-compliance. The current study has concentrated on locating the current regulations and practices in this field and comprehending the fundamental ideas for post approval compliance for licenses relevant to marketing permission. Though change management is essential to a pharmaceutical's lifespan that is the study's main finding. However, the expense of compliance has escalated due to a lack of a clearly defined framework and a lack of understanding of the same, which has led to step-motherly treatment being applied to compliance and license maintenance.
 Conclusion
 Europe has the highest thought-due approval rates worldwide. The European Medicines Agency (EMA) aims to guarantee that patients in the EU have access to medicines that are of the highest caliber, are reliable, and are secure. Public regulatory agencies have the responsibility of ensuring that pharmaceutical firms follow the law. In order to ensure patient safety and well-being, laws mandate that pharmaceuticals be created, tested, tracked, and manufactured in compliance with the standards. A guideline, in addition to the European legislation that defines variation types, gives out a harmonized list of anticipated variations with categorization codes. A defined list of variations for European
 A MA has existed since 1998. Legislation has been amended on a regular basis, and the most recent amendment, in August 2013, made implementation mandatory at the national level, and the variation process was totally harmonized across the EU.

ПРАВИЛА РЕГИСТРАЦИИ И ЭКСПЕРТИЗЫ ЛЕКАРСТВЕННЫХ СРЕДСТВ В РАМКАХ ЕВРАЗИЙСКОГО ЭКОНОМИЧЕСКОГО СОЮЗА: ОЦЕНКА КЛЮЧЕВЫХ ИЗМЕНЕНИЙ

The formation of a common pharmaceutical market within the framework of the Eurasian Economic Union requires the harmonization and unification of procedures for registration and examination of medicines. Changes made annually to the Rules for Registration and Expertise, their analysis and evaluation contribute to the optimization of this process. The goal is to evaluate the key changes made to the Rules for Registration and Expertise of Medicines over the past two years by a group of experts. Materials and methods. The expert group included 38 specialists with experience in registration of medicinal products and making changes to the registration dossier. The evaluation was carried out according to the Likert scale using the developed expert evaluation card. Results. It is shown that, in general, experts are very positive about the changes, both from the standpoint of their practical significance and the optimal ratio of stability and flexibility, and in terms of accuracy, correctness and clarity of formulations. Particularly noted were the creation of the necessary conditions for the active circulation of orphan drugs, their accelerated use in a number of individual cases, the increase in the availability of unregistered drugs in special cases, the exclusion of the annual re-evaluation of the “benefit-risk” indicator for a number of drugs, accelerating mutual recognition procedures in several Member States through simultaneous initiation. Conclusion. The strengths and weaknesses of the amendments to the Rules for Registration and Expertise of Medicines have been established. The need for a more detailed consideration of the amendments concerning the terms of the procedures for registration and expertise of medicines, as well as the assessment of changes in the annexes to the Rules, is shown.

Review on: Dossier submission in the European countries by using mutual recognition procedure and decentralized procedure

There is different procedure used to submit drug product for marketing authorization process. Mutual recognition procedure (MRP) is one of them. The European commission had published the procedure in consultation with competent authorities of member state. Using MRP, the applicant can apply for marketing authorization in one or more European Union nations. (MAH) who already holds authorization for a medical product in a EUROPEAN UNION (EU) member state can use the mutual recognition method to get authorization in additional EU member states. Directive 2004/27/EC established the decentralized procedure. Because the mutual recognition mechanism is also reliant on national authorities recognizing a first assessment done by one-member state, the distinction is that it only applies to pharmaceutical products that do not yet have a marketing authorization at the time of application.

Current Regulations for Marketing Authorization and Procedure for Filing of Active Substance Master File (ASMF) in European Union: A Case Study

Active Pharmaceutical Ingredient is an ingredient in a drug product that is biologically active. A Drug Product will contain two components, one is the Active Ingredient and the other is the Excipients part. Drug Product that has to be placed in the European market needs to have a marketing authorization. Marketing Authorization is the process in which the drug product is evaluated for its safety and compliance with the standards laid down by the Regulatory Authority, considering the safety of patients and public. There are different Procedures for the application of Marketing Authorization. Applicants can either apply for marketing authorization through centralized procedure, decentralized procedure, mutual recognition procedure or the nationalized procedure. Active Substance Master File (ASMF) is a Regulatory Dossier that helps provide confidential data pertaining to the Active Substance to the regulatory authority. This master file shall contain data from the research of the product to the development and lifecycle of the product. ASMF contains two parts, the restricted part and the open part. Both of these parts of ASMF shall not be shared to anyone without a written consent from the ASMF Holder. This master file makes it easy for the application of any Marketing authorization and also makes it easy for the regulators to access all the required data. European Union thus has laid down many Regulations and guidelines for the application of Marketing Authorization and also on how an ASMF is filed in European Union. The current work aims at methodically analyzing the guidance documents that are available and thus help in the review of regulations for the application of Marketing Authorization and also in knowing the process for the filing of Active Substance Master File (ASMF) in the European Market.

Vaccine Licensure

Vaccines must meet the highest standards for safety and efficacy, as they are used for prevention of diseases in healthy subjects, not as treatment for disease. Vaccines are biological products (live or inactivated whole microorganisms or extracts thereof, sometimes heterogenous composition, sensitive to manufacturing conditions, etc.), and thus by their nature they are different from other medicines. The licensing process itself – from development and manufacturing to evaluation of safety and effectiveness post licensure – are the product: “Development and production processes are the licensed product.” In the USA, licensing granted by the FDA encompasses two phases: an “Investigational New Drug” (IND-) phase” and a “Biologics License Application (BLA-) phase” with defined timelines and procedures. There are several ways to accelerate vaccine development and licensing if it is of high public health interest. To support licensure, efficacy must usually be shown by disease reduction in high-quality randomized controlled clinical trials (RCTs). Alternatively, licensure can be obtained based on RCTs using a validated “correlate of protection”, or animal studies if human clinical studies are not feasible. A “surrogate of protection” that is reasonably likely to predict clinical benefit may be used to support conditional licensure under the Accelerated Approval pathway with a commitment to conduct a clinical endpoint efficacy study as a post-approval commitment. For the European Union (EU) and the three European Economic Area (EEA) states, the European Medicines Agency (EMA) is responsible for vaccine licensure. Here vaccines can be licensed by a (1) Centralized Procedure, (2) Mutual Recognition, (3) Decentralized Procedure, or (4) National Procedure. In addition, for licensed vaccines, “WHO prequalification” offers a way to provide existing affordable, safe, and effective vaccines to resource-poor countries.

Overview of Vaccine Regulations in European Union and Japan

In this article we identified the important considerations, in particular , on the preclinical assessments that would allow vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region like National procedure, Decentralized procedures, Centralized procedure, Mutual Recognition Procedure (MRP) monitored by European Medicines Agency (EMA) in Europe , Pharmaceuticals and Medical Devices Agency (PMDA) in relation with Ministry of Health, Labour and Welfare (MHLW) (determines if a proposed study meets the regulatory filing requirements in Japan), The various different types of vaccine regulations was studied with its approval , and development procedure are discussed.

The right of defence under Regulation (EU) 2018/1805 on the mutual recognition of freezing orders and confiscation orders

The article analyses the position of persons affected by the mutual recognition procedures under Regulation (EU) 2018/1805 of the European Parliament and of the Council of 14 November 2018 on the mutual recognition of freezing orders and confiscation orders, assessing whether the rights of defence that can be exercised therein are sufficient to effectively safeguard the interests of such persons.

Mutual Recognition Procedure for the Registration of Medicines: New Challenges or Opportunities

Introduction. An important task for pharmaceutical manufacturers is to bring high quality, effective and safe medicines to the market. In the event that the country's resources are not enough, drugs that have been successfully registered in other countries come to the rescue.Aim. To study the possibilities and advantages of the procedure of mutual recognition of registration medicinal products as a potential for the development of domestic producers.Materials and methods. The materials of the study were available publications in peer-reviewed journals on thematic queries based on keywords of the selected topic, official websites, regulatory legal acts, regulating the procedure for registering medicinal products in the EU and the Russian Federation.Results and discussion. New approaches to registration within the framework of the Eurasian Economic Union (using the example of the mutual recognition procedure) are considered from the perspective of new opportunities and emerging problems for domestic manufacturers of generic drugs. A comparative analysis of the mutual recognition procedure and the national procedure for registration of medicinal products revealed a number of advantages for domestic manufacturers, favoring the introduction of medicinal products into circulation on the territory of the EAEU.Conclusion. The review of the process of harmonization of the registration practice of medicinal products in the EAEU speaks of the prospects of using the mutual recognition procedure for developing the potential of domestic manufacturers and facilitating access to effective and safe drugs.

Impact of Brexit on Zonal Approval Procedures and Mutual Recognition Procedures in Plant Protection Legislation

On 29 March 2017, the UK made use of Article 50 of the Treaty on European Union (TEU) and thus initiated its withdrawal from the European Union. As a result, the UK left the European Union on 31 January 2020 (23:00 UTC). This paper provides a legal assessment of the impact of the UK’s withdrawal from the European Union (Brexit) on zonal authorisation and mutual recognition procedures regarding the authorisation of plant protection products. Many legal issues are unclear in this respect due to the lack of European and national case law. The German Administrative Court of Braunschweig had to decide in an urgent procedure on the effects of Brexit with regards to the authorisation of a plant protection product in the mutual recognition procedure.

Levodopa/Carbidopa Enteral Suspension: A Review in Advanced Parkinson's Disease.

An enteral suspension (ES)/intestinal gel formulation of levodopa/carbidopa (hereafter referred to as levodopa/carbidopa ES) [Duodopa® (EU); Duopa™ (USA)] has been developed to overcome the fluctuating plasma levodopa concentrations associated with oral levodopa/carbidopa formulations. In various countries, including those of the EU (under the Mutual Recognition Procedure), it is approved for the treatment of advanced levodopa-responsive Parkinson's disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. In several other countries, including the USA, it is approved for the treatment of motor fluctuations in patients with advanced PD. In adults with advanced PD, levodopa/carbidopa ES improved motor fluctuations, activities of daily living and health-related quality of life (HR-QOL) during short-term (12-week) treatment, with the beneficial effects on motor fluctuations largely sustained over the longer term (up to 7years). Levodopa/carbidopa ES was generally well tolerated in this patient population, with adverse events (AEs) associated with aging, advanced PD-related comorbidities, the procedure/device or dopaminergic therapy. Its safety profile was comparable to that of oral levodopa/carbidopa with respect to non-procedure/device-associated AEs; most procedure/device-associated AEs were consistent in nature and incidence with medically recognised complications of the procedure in non-PD patients. Current evidence indicates that levodopa/carbidopa ES is an effective and generally well tolerated option for the treatment of motor fluctuations in patients with levodopa-responsive advanced PD who are not being effectively managed with non-invasive therapies.

ACTIVATION OF ACADEMIC MOBILITY OF STUDENTS OF HIGHER EDUCATION INSTITUTIONS AS A MEANS OF ENHANCING THEIR COMPETITIVENESS: HOME AND GREEK EXPERIENCE

The article is devoted to the coverage of home and Greek experience in providing the academic mobility of students of higher education institutions. It’s found out that several factors contributed to its development in Ukraine, such as: improving the legislative base, signing an agreement on a visa-free regime with Ukraine, improving and applying the mutual recognition procedure for education documents, and Ukraine's accession to the Erasmus + program. It has been stated that the following negative internal processes hinder the activation of academic mobility: the country economic characteristics (the difference between the standard of living in Ukraine and the countries of the European Union), the quality and cost of studying and living, the availability of household services, compliance with European educational standards, insufficient level of foreign language skills, lack of information students get concerning exchange programs, etc. The peculiarities of the realization of the right of Greek universities students to academic mobility are analyzed basing on the example of law faculties of Democritus University of Thrace and the National and Kapodistrian University of Athens. It has been established that students of Greek universities can take part in the following programs: for studying in foreign partner universities; for participating in various types of practical programs in foreign partner universities. The procedure of students’ participation in practical programs is described in detail, namely the length of practical training, the categories of people who can participate in the relevant programs, the list of documents to be submitted for participation in the program, the criteria for selecting applicants, the size of the scholarship are found out. The emphasis is on the important innovation of relevant programs, which consists in the fact that Erasmus + provides students with free language Internet-support in the study of the appropriate foreign language before and during their stay abroad. The article analyzes the peculiarities of the organization of the master's degree programs in Greek universities together with foreign universities giving the identic diploma of a master's degree. In particular, the master’s program “Specialized Public Law”, organized by the legal department of the National and Kapodistrian University of Athens together with the University of Montesquieu-Bordeaux IV (France), is described. Taking into account the experience of the Greek universities, the range of issues that need to be resolved in the national system of higher education is highlighted. These include improving of state financing of exchange programs; comprehensive informing of students about such programs; organization of joint master’s degree programs of home and foreign universities; increasing the level of foreign language communicative competence of students.

Maximum Vitamin Amounts in Food Supplements: Towards Science-based and Streamlined EU Mutual Recognition and Risk Assessment Procedures?

Maximum Vitamin Amounts in Food Supplements: Towards Science-based and Streamlined EU Mutual Recognition and Risk Assessment Procedures?

MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET

This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.

Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe

The marketing authorisation process is an integral part of the life cycle of a veterinary medicinal product, which the applicant wishes to market. The costs of the marketing authorisation of veterinary medicinal products are different from state to state. The differences in marketing authorisation fees are also between particular types of the marketing authorisation procedure such as the national procedure, mutual recognition procedure, decentralised procedure and centralised procedure and whether certain state is the reference member state or concerned member state particularly applicable in either a mutual recognition procedure or a decentralised procedure. The fees is also depended on the type of the marketing authorisation application, such as full, generic, hybrid, similar biological, well established use, fixed combination or informed consent and eventually whether a reference veterinary medicinal product is marketed in the state or not specifically for generic, hybrid and similar biological applications. If it is focused on the states in northern Europe, where Finland, Sweden, Norway, Iceland, Denmark and Baltic States Estonia, Latvia and Lithuania are included, it is a very varied group of states, where each competent authority has its own approach to the determination of marketing authorisation fees. It is important to mention that the marketing authorisation fees for veterinary medicinal products mostly are not the same as the fees for human medicinal products and also even this is paid attention.

The Right to Liberty in European Union Law and Mutual Recognition in Criminal Matters

AbstractThis article analyses the interaction between the application of mutual recognition in criminal matters and the right to liberty. The main argument is that the current content of the right to liberty in EU law is unsuitable for mutual recognition procedures. As for the structure of this article, firstly, the main features of mutual recognition as a method of inter-state cooperation in criminal matters are outlined. Secondly, the approach of the European Union (especially the Court of Justice) to the right to liberty is clarified. Thirdly, four mutual recognition instruments are analysed in light of the right to liberty: namely, the Framework Decisions on the European Arrest Warrant; the Transfer of Prisoners; the Probation Measures; and the European Supervision Order (ESO). The assessment confirms that the higher level of automaticity in judicial cooperation introduced by mutual recognition requires a rethink of the existing understanding of the right to liberty in EU law.

Green tea extract for external anogenital warts

Catephen (Kora Corporation Ltd) is a herbal medicinal product consisting predominantly of catechins (sinecatechins) extracted from Camellia sinensis (L.) O. Kuntze folium (green tea leaf) formulated as a topical preparation...

The approval process of medicines in Europe

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising each other's evaluations (the so called decentralised and mutual recognition procedures). It is a system that has evolved over the past half century from one with wholly separate national systems to one where EU countries now harness their regulatory and scientific expertise to harmonise and improve the evaluation of medicines across Europe. Today, the purely national procedure is rarely used by applicants and only when they seek marketing authorisation in a single Member State. Although the different procedures may give an impression of complexity, they have simplified the authorisation process across Member States, reducing the times for new medicines to obtain marketing authorisation and improving patient access to new medicines.

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Überblick über die Entwicklung der europäischen Rechtsetzung zur Angleichung der Arzneimittelvorschriften

The harmonisation of the legislation for medicinal products is an on-going process even after 40 years of development. The first step for harmonising the requirements for the marketing authorisation and monitoring took place with the introduction of the first pharmaceutical directive in 1965. Further components of European legislation such as directives, which have to be transposed into national law by the Member States, and regulations, which take effect immediately, have been adopted since then. The latest fundamental progress made in the process of harmonising the European market for medicinal products was the adoption of Directive 2004/27/EG in the framework of the Pharma-Review 2002. In addition to the existing centralised procedure and mutual recognition procedure a decentralised procedure and the enlargement of the area of authority of the European Medicines Agency were introduced. Lately new laws for medicinal products for children and advanced therapies were introduced through a regulation.

Registrierung neuer Arzneimittel in Europa

Im Jahr 1995 nahm die 1993 gegründete Europäische Arzneimittelagentur, die EMEA (European Medicines Agency), ihre Arbeit auf. Sie hat fünf wissenschaftliche Ausschüsse, die für die Registrierung von Arzneimitteln (AM) zuständig sind. Der für Humanarzneimittel wichtigste ist der Ausschuss für Humanarzneimittel, das CHMP (Committee for Medicinal Products for Human Use). Zum selben Zeitpunkt wurden für die Registrierung von AM zwei Verfahren installiert, das zentralisierte Verfahren und das Verfahren der gegenseitigen Anerkennung. Erstgenanntes ist verpflichtend für biotechnologisch hergestellte AM sowie für AM gegen Krebs, HIV/AIDS, Diabetes, neurodegenerative Erkrankungen und seltene Leiden («orphan drugs»). Alle AM im zentralen Verfahren werden vom CHMP beurteilt. Alle anderen AM unterliegen dem Verfahren der gegenseitigen Anerkennung, bei dem eine in einem EU-Staat erteilte Zulassung auf Antrag des Herstellers auf andere EU-Staaten erweitert wird. Im Zeitraum von 1995 bis 2004 wurden im zentralen Verfahren 243 Zulassungen erteilt; 20% davon fallen auf den onkologischen Bereich. Die neuen Verfahren haben zu einer wesentlichen Vereinheitlichung und Beschleunigung der Registrierung von AM in Europa geführt.